<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20230119057157N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2023-02-15</date_registration>
      <primary_sponsor>The university of Semnan</primary_sponsor>
      <public_title>The Comparison Effectiveness of acceptance and commitment therapy with exposure and response prevention and schema therapy with exposure and response prevention on obsession compulsion disorder</public_title>
      <acronym></acronym>
      <scientific_title>The Comparison Effectiveness of acceptance and commitment therapy with exposure and response prevention and schema therapy with exposure and response prevention on obsession, experiential avoidance, perfectionism and psychological distress in patient with obsession and compulsion disorder</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-02-20</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>54</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/68147</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Assigning people to groups is simple random. After selecting people as samples, a list of them is prepared (For example, 01,02, … ,60), Then, in the random number table, a row and a column are randomly selected and their intersection is determined as the starting point. It is predetermined whether the direction of reading the numbers is left, right, up or down and which two digits of the number in the random number table determine each person's number (for example, the middle two digits). After selecting 20 people for the first group, 20 people for the second group, and 20 people for the third group, the next step is assigning the groups. First, the names of the groups are written on 3 separate papers and they are folded 4 times so that there is no view of the writings. The papers are put in a container and place them randomly in separate folders with three different colors, green, yellow and red. At this stage, the researcher does not know what group is inside each folder. Green, yellow and red colors are written on the other three papers and they are folded 4 times. they are put into a container and the papers are randomly selected and the groups are determined. For example, if the first lottery was green and in the green folder was schema therapy with exposure and response prevention, the people who were selected in the first group with random number table will be placed in the schema therapy with exposure and response prevention group.</study_design>
      <phase>N/A</phase>
      <hc_freetext>obsession compulsion disorder.</hc_freetext>
      <i_freetext>Intervention 1: The first intervention group: acceptance and commitment therapy with exposure and response prevention. This treatment consists of 8 sessions and is held every week for 45 minutes. The goals of this therapy include increasing psychological flexibility, Decreased experiential avoidance, Teaching mindfulness exercises to observe thoughts and anxiety, Non-judgment to inner experiences, Creating a hierarchy of compulsive activities and tendency to experience discomfort, Clarification and classification of values ​​and exposure and response prevention based on values, Removing barriers to exposure and response prevention, Practicing uncertainty and incompleteness and creating meaningful moments and daily commitment to values, Increasing the quality of life and preventing relapse and modifying lifestyle. Intervention 2: The second intervention group: schema therapy with exposure and response prevention, This treatment consists of 8 sessions and is held every week for 45 minutes. The treatment will include three parts: introduction and familiarization, change and the final part. Treatment goals include identifying primary maladaptive schemas, Creating a hierarchy of obsessions and hierarchical exposure and response prevention during treatment, Adjustment of  primary maladaptive schemas, Transferring new learned skills from the treatment to the home environment, Prevent recurrence. In order to achieve the therapeutic goals, the technique of empty chair, the technique of rewriting painful  images and memories and schematic notes are used. Intervention 3: Control group: At first This group completes the pre-test and does not receive any intervention and remains on the waiting list. After the end of the sessions of the experimental groups, post-test will be taken from this group. In order to comply with research ethics, After completing the intervention in the experimental groups, the control group will receive intervention.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
All participant's information will be shared but their names will be removed.

When:
The access starts one year after the publication of the results

To whom:
Only faculty members in psychology

Conditions:
Meta-analysis is allowed

Where to obtain:
Send request to this email:
mahnaz.samani@gmail.com

How to obtain:
Data will be sent within two weeks after request

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahnaz Ghatreh Samani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, Golshan Ave., Golzar 3 Ave., Zobahan Highway</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8178677553</zip>
        <telephone>+98 31 3780 3703</telephone>
        <email>mahnaz.samani@gmail.com</email>
        <affiliation>The university of Semnan</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahnaz Ghatreh Samani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>No. 33, Golshan Ave., Golzar Ave., Zobahan Highway</address>
        <city>Isfahan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>8178677553</zip>
        <telephone>+98 31 3780 3703</telephone>
        <email>mahnaz.samani@gmail.com</email>
        <affiliation>The university of Semnan</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Diagnosis of obsessive-compulsive disorder
Minimum education is12th grade
People whose insight into their disorder is good or sufficient, and low
People whose score in the Yale Brown Questionnaire is less than 25
People whose duration of obsessive-compulsive disorder is less than 2 years
People whose obsessive-compulsive disorder is not so severe as to impair their cognition</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>The presence of other coexisting disorders
Other parallel psychiatric treatments
People whose disorder is so severe that their cognition is impaired
People who have no insight into their disorder or have delusional beliefs</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F42</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Obsessive-compulsive disorder</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Other</i_code>
      <i_code>Other</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>The first intervention group: acceptance and commitment therapy with exposure and response prevention. This treatment consists of 8 sessions and is held every week for 45 minutes. The goals of this therapy include increasing psychological flexibility, Decreased experiential avoidance, Teaching mindfulness exercises to observe thoughts and anxiety, Non-judgment to inner experiences, Creating a hierarchy of compulsive activities and tendency to experience discomfort, Clarification and classification of values ​​and exposure and response prevention based on values, Removing barriers to exposure and response prevention, Practicing uncertainty and incompleteness and creating meaningful moments and daily commitment to values, Increasing the quality of life and preventing relapse and modifying lifestyle.</i_keyword>
      <i_keyword>The second intervention group: schema therapy with exposure and response prevention, This treatment consists of 8 sessions and is held every week for 45 minutes. The treatment will include three parts: introduction and familiarization, change and the final part. Treatment goals include identifying primary maladaptive schemas, Creating a hierarchy of obsessions and hierarchical exposure and response prevention during treatment, Adjustment of  primary maladaptive schemas, Transferring new learned skills from the treatment to the home environment, Prevent recurrence. In order to achieve the therapeutic goals, the technique of empty chair, the technique of rewriting painful  images and memories and schematic notes are used.</i_keyword>
      <i_keyword>Control group: At first This group completes the pre-test and does not receive any intervention and remains on the waiting list. After the end of the sessions of the experimental groups, post-test will be taken from this group. In order to comply with research ethics, After completing the intervention in the experimental groups, the control group will receive intervention.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severity of obsession compulsion disorder. Timepoint: before and after intervention. Method of measurement: Yale Brown Questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Obsessive Beliefs. Timepoint: before and after intervention. Method of measurement: The Obsessive Beliefs Questionnaire.</sec_outcome>
      <sec_outcome>Perfectionism. Timepoint: before and after intervention. Method of measurement: Frost Multidimensional Perfectionism Scale.</sec_outcome>
      <sec_outcome>Experiential Avoidance. Timepoint: before and after intervention. Method of measurement: Acceptance and Action Questionnaire-II.</sec_outcome>
      <sec_outcome>Psychological distress. Timepoint: before and after intervention. Method of measurement: Depression Anxiety and Stress Scale.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>The university of Semnan</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-12-26</approval_date>
        <contact_name>Research Ethics Committees of Semnan University Of Medical Sciences and Health Services</contact_name>
        <contact_address>Basij Blvd., Semnan Semnan Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
